Senior Executive/Asstt. Manager- Regulatory Affairs

Job Description

To be responsible for Review and submit the Abbreviated New Drug Applications (ANDA) for US market and submit the Marketing Authorization Applications (MAA) for EU region

KEY RESULT AREA

Review and submission of ANDA Review and submission of responses to the queries Review of all documents related AD , PD, QA, MA & Plant

KEY FUNCTIONS / RESPONSIBILITIES

1. Review and submit the Abbreviated New Drug Applications (ANDA) for US market and submit the Marketing Authorization Applications (MAA) for EU region. 2. Initiate the submission of all the dossiers in eCTD format across US and EU. 3. Initiate the submission of eLabeling i.e., SPL and PLR for US market. 4. Review and submit responses for the queries received from the USFDA and EU regulatory agencies. 5. Review and submit the supplements & variations for filing the post approval changes in the US and EU region. 6. Review the analytical document of raw material and finished products specifications & test procedures, packaging material specifications & test procedures, in-process specifications & test procedures, analytical method validation protocols and reports etc. 7. Review the development documents like master formula records, product development reports and stability protocols etc. 8. Review the plant documents like batch manufacturing records, process validation protocols and process validation reports etc. 9. Ensure the compliance of the registration dossier in line with the practice at plant. 10. Update the team members by providing various presentations on regulatory topics.